NDC 54092-477

MYDAYIS

Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, And Amphetamine Sulfate

MYDAYIS is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate.

Product ID54092-477_04e5e827-7eae-474a-bbc6-ad34b8479958
NDC54092-477
Product TypeHuman Prescription Drug
Proprietary NameMYDAYIS
Generic NameDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, And Amphetamine Sulfate
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-06-20
Marketing CategoryNDA / NDA
Application NumberNDA022063
Labeler NameTakeda Pharmaceuticals America, Inc.
Substance NameAMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active Ingredient Strength13 mg/1; mg/1; mg/1; mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 54092-477-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-477-01)
Marketing Start Date2017-06-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54092-477-01 [54092047701]

MYDAYIS CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022063
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-20

Drug Details

Active Ingredients

IngredientStrength
DEXTROAMPHETAMINE SULFATE12.5 mg/1

OpenFDA Data

SPL SET ID:141a7970-3f06-44ea-9ab7-aeece2c085fc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1927610
  • 1927617
  • 1927616
  • 1927619
  • 1927630
  • 1927632
  • 1927639
  • 1927637
  • Pharmacological Class

    • Central Nervous System Stimulant [EPC]
    • Central Nervous System Stimulation [PE]
    • Central Nervous System Stimulant [EPC]
    • Central Nervous System Stimulation [PE]
    • Central Nervous System Stimulant [EPC]
    • Central Nervous System Stimulation [PE]
    • Central Nervous System Stimulant [EPC]
    • Central Nervous System Stimulation [PE]

    Medicade Reported Pricing

    54092047701 MYDAYIS ER 50 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "MYDAYIS" or generic name "Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, And Amphetamine Sulfate"

    NDCBrand NameGeneric Name
    54092-468MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE
    54092-471MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE
    54092-474MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE
    54092-477MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE

    Trademark Results [MYDAYIS]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MYDAYIS
    MYDAYIS
    87604835 5488273 Live/Registered
    Shire LLC
    2017-09-12
    MYDAYIS
    MYDAYIS
    87510639 not registered Dead/Abandoned
    Shire LLC
    2017-06-29
    MYDAYIS
    MYDAYIS
    86670108 5276898 Live/Registered
    Shire LLC
    2015-06-22
    MYDAYIS
    MYDAYIS
    86281912 5261446 Live/Registered
    Shire LLC
    2014-05-15

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